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Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Marga F. Massey, M.D., The National Institute of Lymphology.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273909
First Posted: January 11, 2011
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The DrMarga Practice Group
The Center for Restorative Breast Surgery, LLC
Information provided by (Responsible Party):
Marga F. Massey, M.D., The National Institute of Lymphology
January 7, 2011
January 11, 2011
June 6, 2014
July 2010
January 2016   (Final data collection date for primary outcome measure)
Change in BreastQ Questionnaire and Lymphedema Severity Score [ Time Frame: Baseline and 6 months after surgery ]
Change in BreastQ Questionnaire and Lymphedema Severity Score [ Time Frame: 6 months after surgery ]
Complete list of historical versions of study NCT01273909 on ClinicalTrials.gov Archive Site
Persistent Postsurgical Pain assessment questionnaire [ Time Frame: 6 months after surgery ]
Same as current
Not Provided
Not Provided
 
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema.

The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.

Breast cancer is a serious health issue that affects 1 in 8 women. Although numerous treatments have arisen in recent years to aggressively combat this disease and increase survivorship, many survivors develop a crippling condition that can result in devastating physical and psychological impairments. Breast reconstruction by any method may help recovery psychologically. However, some individuals still report experiencing pain following their recovery from surgery. Additionally, secondary lymphedema is a common yet poorly understood complication of breast cancer patients. For those individuals who undergo axillary lymph node dissection the rates of incidence of lymphedema approach 47%. These rates tend to increase further for patients who receive irradiation treatment or mastectomies. Currently there is no known cure for lymphedema. Current treatments include non-invasive measures as well as surgical interventions. Vascularized lymph node transfer (VLNTx) is a fairly recent surgical procedure that has shown promising results.

The goal of this research study is to analyze the clinical outcome of subjects who undergo breast reconstruction with perforator flaps and/or VLNTx using information collected as part of standard care.

Clinical data will be collected prospectively. All subjects who undergo a surgical procedure will complete the online persistent postsurgical pain assessment questionnaire.

The BreastQ questionnaire will be completed by patients prior to and after undergoing breast reconstruction and/or lymphedema treatment.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All subjects who are patients of the "Dr Marga" Practice or the Center for Restorative Breast Surgery that consent to participate in this research study will be selected. There is no age, ethnicity or gender requirement.
  • Breast Cancer
  • Hereditary Breast/Ovarian Cancer (brca1, brca2)
  • Acquired Lymphedema
  • Congenital Lymphedema
  • Procedure: Perforator Flap Breast Reconstruction
    perforator flap breast reconstruction with or without vascularized lymph node transfer
    Other Names:
    • DIEP Flap
    • SGAP Flap
    • IGAP Flap
    • SIEA Flap
    • TUG Flap
    • TDAP Flap
    • ICP Flap
  • Procedure: Vascularized Lymph Node Transfer
    perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
    Other Name: VLNTx
  • Perforator Flap Breast Reconstruction
    Patients who undergo perforator flap breast reconstruction with or without concomitant vascularized lymph node transfer
    Interventions:
    • Procedure: Perforator Flap Breast Reconstruction
    • Procedure: Vascularized Lymph Node Transfer
  • Vascularized Lymph Node Transfer
    Patients who undergo perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
    Interventions:
    • Procedure: Perforator Flap Breast Reconstruction
    • Procedure: Vascularized Lymph Node Transfer

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1000
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema

Exclusion Criteria:

  • Pregnant
  • unable to read
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01273909
MFM001
1116697 ( Other Identifier: Western Institutional Review Board )
No
Not Provided
Not Provided
Marga F. Massey, M.D., The National Institute of Lymphology
The National Institute of Lymphology
  • The DrMarga Practice Group
  • The Center for Restorative Breast Surgery, LLC
Principal Investigator: Marga F. Massey, M.D. National Institute of Lymphology
The National Institute of Lymphology
June 2014